恩诺单抗治疗相关皮肤反应作为生存和治疗反应的替代标志物

Treatment-related skin reactions in enfortumab vedotin as a surrogate marker of survival and treatment response.

作者信息

Nagayama Jun, Inoue Satoshi, Sai Hiroki, Hayakawa Akira, Yuguchi Yuri, Suzuki Tomohide, Matsui Hirotaka, Yuba Takuma, Morishita Koya, Akamatsu Shusuke

机构信息

Department of Urology, Nagoya University Graduate School of Medicine, 65 Tsuruma-cho, Showa-Ku, Nagoya, Aichi, 466-8550, Japan.

Department of Urology, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, Nagoya, Japan.

出版信息

Int J Clin Oncol. 2025 Feb;30(2):267-276. doi: 10.1007/s10147-024-02672-3. Epub 2024 Dec 16.

DOI:10.1007/s10147-024-02672-3

PMID:39681749

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11785594/

Abstract

BACKGROUND

Treatment-related skin reactions (TRSRs) induced by enfortumab vedotin (EV) targeting nectin-4 are among the most common adverse events. However, their association with survival and treatment response is poorly understood.

METHODS

We retrospectively identified patients who received EV from December 2021 to April 2023 at Nagoya University Hospital and its affiliated facilities and extracted clinical data from their medical records. We evaluated cancer-specific survival (CSS) and progression-free survival (PFS) as survival outcomes and overall response rate (ORR) and disease control rate (DCR) as treatment responses between patients with and without TRSRs.

RESULTS

In total, 67 eligible patients were identified. Thirty-four patients experienced TRSRs, and the remaining 33 did not experience TRSRs. The median follow-up period was 8 months. Patients in the TRSRs group demonstrated significantly longer median CSS (15 vs. 8 months; p = 0.003) and median PFS (10 vs. 5 months; p < 0.001) than the non-TRSRs. Regarding treatment response, the patients in the TRSRs group showed a favorable, albeit nonsignificant, treatment response trend compared with those in the non-TRSRs group (ORR, 73.5% vs. 51.5%; p = 0.107; DCR, 91.2 % vs. 81.8%; p = 0.444).

CONCLUSIONS

Patients with TRSRs demonstrated more prolonged survival and superior treatment responses to EV treatment. The role of TRSR as a surrogate marker of EV's efficacy should be further explored in prospective and sufficiently powered studies.

摘要

背景

由靶向nectin-4的恩诺单抗（EV）引起的治疗相关皮肤反应（TRSRs）是最常见的不良事件之一。然而，它们与生存和治疗反应之间的关联尚不清楚。

方法

我们回顾性确定了2021年12月至2023年4月在名古屋大学医院及其附属机构接受EV治疗的患者，并从他们的病历中提取临床数据。我们评估了癌症特异性生存（CSS）和无进展生存（PFS）作为生存结局，以及总缓解率（ORR）和疾病控制率（DCR）作为有和没有TRSRs患者之间的治疗反应。

结果

总共确定了67例符合条件的患者。34例患者经历了TRSRs，其余33例未经历TRSRs。中位随访期为8个月。TRSRs组患者的中位CSS（15个月对8个月；p = 0.003）和中位PFS（10个月对5个月；p < 0.001）明显长于非TRSRs组。关于治疗反应，与非TRSRs组相比，TRSRs组患者显示出有利的、尽管不显著的治疗反应趋势（ORR，73.5%对51.5%；p = 0.107；DCR，91.2%对81.8%；p = 0.444）。